Prevention of Medication Overuse (MO) and Medication Overuse Headache (MOH): A randomized, controlled, parallel, multicenter, prospective trial using a mobile application software

Not Applicable

Recruiting

• Conditions: G43; G44.4; F55.2; Migraine; Drug-induced headache, not elsewhere classified

• Registration Number: DRKS00025961
• Lead Sponsor: niversitätsklinikum Essen in Wahrnehmung der Aufgaben der Universität Duisburg-Essen, Campus Essen, Fachbereich Medizin; Institution: Institut für Medizinische Informatik, Biometrie und Epidemiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

1) Migraine patients: Patients with frequent episodic migraine (EM) (= 8-14 headache days/month, of which 4 fulfill IHS criteria for migraine) or chronic migraine (CM) (=15 headache days/month, of which 8 fulfill IHS criteria for migraine)

OR

Post-MO(H)-Patients: Patients, who underwent treatment for MO(H) (initially = 15 headache days/month, intake of attack aborting medication on 10 or more or 15 or more days/month according to International Classification of Headache Disorders (ICHD-3) criteria of mediation overuse headache (MOH))

AND
2) Owning a mobile device with iOS or Android system, which is able to run the App
3) Adults = 18 years
4) Written informed consent consistent with ICH-GCP (International Conference of Harmonization – Good Clinical Practice) guidelines and local laws signed prior to all study-related procedures
5) Compliance for using the App on = 80% days during the screening period

Exclusion Criteria

1) Patients with concomitant primary headache disorders, other than EM or CM (except tension-type headache < 15 days/month)
2) Current MO upon the discretion of the treating physician (intake of attack aborting medication on =10 days/month within the last 3 months)
3) Co-morbidity interfering with the study outcomes upon the discretion of the treating physician
4) Intake of opioids on > 3 days/month
5) Regular intake (> 15 days/month) of (i) hypnotics, (ii) benzodiazepines as sedatives (tranquillizer), (iii) antipsychotics (neuroleptics) in psychiatric indication
6) Parallel use of other migraine apps to track headache days and medication intake

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients developing MO or MOH according to ICHD-3 for at least 3 consecutive months between baseline and end of study visit.

Secondary Outcome Measures

Name	Time	Method
Migraine specific disability assessment (MIDAS) score; <br><br>Number of headache days/month; <br><br>Number of days with attack aborting medication per month; <br><br>Psychiatric comorbidity by means of the Depression Anxiety Stress Scale (DASS) score; <br><br>Severity of headaches; <br><br>Time to MO or MOH; <br><br>For patients, who have reached the primary endpoint during the study: Number of headache days/month and number of days with attack aborting therapy per month in the last study month;<br> <br>Frequency of serious adverse events (SAEs)